Kornimate/medical-research-clean huggingface dataset:
exposure chamber trial with cat immunotherapy

Conditions: Cat Allergy

Summary: the main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients.


Eligibility criteria:
inclusion criteria: * a history of rhinoconjunctivitis on exposure to cats * positive skin prick test response (wheal diameter at least 3 mm larger than the negative control * positive specific ige against fel d1 (at least ige class 2) * minimum qualifying rhinoconjunctivitis symptom score during eec exposure at visit 2 exclusion criteria: * uncontrolled asthma within the past 12 months, or asthma requiring regular use of inhaled corticosteroids * fev1 less than 80% of predicted * subjects who suffer from significant seasonal allergic rhinoconjunctivitis, and cannot complete the clinical trial outside the local pollen season, or who have significant allergy to other allergens (e.g. other animals or house dust mites) that cannot be avoided during the trial period * subjects who cannot tolerate baseline challenge in the environmental exposure chamber * history of anaphylaxis with cardio/respiratory symptoms * a medical history of severe drug or food allergy with symptoms such as difficulty breathing, swelling of the face or a feeling of severe dizziness or increased heart rate * chronic urticaria * history of severe cardiac disease * treatment with immunosuppressives, anti-ige monoclonal antibodies, tricyclic antidepressants or maois

Keywords: cat allergy immunotherapy sublingual exposure chamber safety rhinoconjunctivitis
type 2 diabetes and exercise function in single leg exercises

Conditions: Type 2 Diabetes

Summary: this study plans to learn more about the effects of type 2 diabetes (t2dm) on exercise blood flow and muscle oxygen uptake. this study will evaluate \& compare exercise function during single leg plantar flexion exercise in a total of 45 subjects from the denver area (15 lean controls, 15 people with t2dm, and 15 overweight control subjects). differences between the exercise responses in people with t2dm and healthy people will help further identify the disease process of t2dm and direct future research of treatments and interventions.

it is well established that functional exercise capacity and peak oxygen uptake (vo2) are reduced in patients with type 2 diabetes mellitus (t2dm) compared with healthy counterparts. the mechanisms underlying the exercise deficit in t2dm remain largely unknown, but previous work has suggested that reduced exercise blood flow and impaired submaximal vo2 may be contributing factors. both of these findings are consistent with a peripheral impairment of skeletal muscle oxygen delivery, oxygen utilization, or both. indeed, dysfunction of skeletal muscle metabolism plays a key role in the pathophysiology of t2dm, and considerable work has described abnormalities of oxidative function in the skeletal muscle of people with t2dm. given this, it is likely that the causes of exercise intolerance in t2dm may relate to specific defects at the level of the skeletal muscle, particularly given that skeletal muscle blood flow and oxidative capacity are impaired in diabetes. however, to our knowledge, no one has related these peripheral muscle abnormalities to the diminished exercise function in this patient group. the overarching hypothesis for the proposed research is that both a failure to adequately increase muscle oxygen delivery following the onset of exercise and reduced oxidative function of skeletal muscle contribute to the acute oxygen deficit and diminished exercise tolerance that has been observed in patients with t2dm.

Eligibility criteria:
inclusion criteria: * men and women with and without type 2 diabetes * 30-70 years of age * lean and overweight * sedentary subjects not participating in a regular exercise program (\<one bout of exercise/week) exclusion criteria: * documented cardiovascular disease * uncontrolled hypertension: systolic blood pressure (sbp) \> 150, diastolic blood pressure (dbp)\> 110 * obstructive pulmonary disease or asthma * peripheral neuropathy * subjects taking beta blockers, insulin, or thiazolidinediones (tzd) * current or past smoking within the last 2 years * anemia * control hba1c \> 6, t2dm hba1c \> 10 * type 1 diabetes * any implanted metal in subject's body

Keywords: type 2 diabetes exercise impairment blood flow muscle oxygen uptake exercise training
impulse™ una infrasound-to-ultrasound e-stethoscope

Conditions: Covid19; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome; Mass Screening; Corona Virus Infection; Vaccine Virus Shedding

Summary: this study generates robust, uniform clinical data across emerging covid-19 strains to train ml/ai algorithms of the sponsor's impulse™ una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of asymptomatic and symptomatic covid-19 digital biosignatures for rapid and accurate adult and child mass screening.

for the next few years or more, the planet probably won't have enough vaccine for everyone. even as countries with large covid-19 vaccination programs start pushing to resume travel and trade: we will not know who is vaccinated and who is not . we will not know who is an (a)symptomatic covid-19 carrier and who is not. because of this, the global community will remain in various stages of masking, social distancing, lock-down, and limited congregation because of cyclical covid-19 spikes and people will continue to feel unsafe and afraid as novel covid-19 variants appear and disappear. this large-scale, multi-site, multi-national study is informed by a completed pilot study at johns hopkins- nct04556149. this study is designed to validate the ability of the impulse™ una infrasound-to-ultrasound e-stethoscope to rapidly and accurately screen outpatients with and without confirmed covid-19 with sensitivity, specificity, positive and negative predictive value matching (ppa \>95%) for early, accurate, and rapid, self-directed and point-of-care diagnosis of covid-19 in areas still lagging in access to vaccines.

Eligibility criteria:
inclusion criteria: * able to understand and willingness to comply with study procedures * inpatient cases - hospitalized patients with positive covid-19 pcr test, collected from a respiratory sample within the last 7 days, and pulmonary symptoms within 72 hours of enrollment * outpatient cases - participant being screened for covid-19 with positive covid-19 pcr test respiratory sample controls - outpatients with negative covid-19 pcr test respiratory sample and no pulmonary diagnosis or symptoms cases or control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing. exclusion criteria: * assisted ventilation, including high flow nasal cannula, or ventilator support * unable to comply with study procedures, defined at investigator's discretion * participants with any visible skin infections or open wounds in areas where the impulse™ una device would be applied

Keywords: infrasound ultrasound vibroacoustics vibrome digital-biosignature e-stethoscope
evolution of vestibular function after treatment of a vestibular schwannoma by gamma-knife radio-surgery

Conditions: Vestibular Schwannoma; Neurinoma, Acoustic; Acoustic Neuroma

Summary: the purpose of this study is to evaluate the vestibular effects of gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.

vestibular schwannoma is a benign tumor located on the vestibulocochlear nerve. it represents 6 to 8% of intracranial tumors, 80% of ponto-cerebral angle tumors and its frequency is 13 cases per million inhabitants per year. the main symptoms related to the development of vestibular schwannoma are unilateral deafness of perception, unilateral tinnitus, unilateral vestibular deficit vertigo, facial paralysis. management is divided into 3 options: monitoring, surgery and gamma-knife radiosurgery. this study will focus on gamma-knife radiosurgery. the objective of this treatment is to stabilize the evolution of schwannoma. this study aims to describe the vestibular effects of radiosurgery.

Eligibility criteria:
inclusion criteria : * men and women aged 18 to 90 included * subject who benefited from gamma-knife radiosurgery as part of the treatment of vestibular schwannoma * non-opposition of the subject to participate in the study * affiliation to a french social security scheme or beneficiary of such a scheme exclusion criteria : * subject with another vestibular pathology * subject who did not benefit from a vestibular assessment before treatment with gamma-knife radiosurgery * legal incapacity or limited legal capacity * subject unlikely to cooperate in the study and/or weak cooperation anticipated by the investigator * subject without health insurance * subject being in the period of exclusion from another study or provided for by the "national volunteer file".

Keywords: vestibular schwannoma radiosurgery gamma-knife neurinoma acoustic
probiotics' effects on hormones, body and mood in obese women

Conditions: Obesity, Women

Summary: to evaluate the regulatory effect of probiotics formula on visceral fat metabolism and sex hormone balance in obese women.


Eligibility criteria:
inclusion criteria: age: 18 to 40 years old, female, bmi ≥ 25 kg/m2. be willing to receive follow-up during the intervention period. be willing to provide two blood, urine and fecal samples during the intervention period. be willing to take the compound probiotics by oneself every day during the intervention period. have good hearing and be able to hear and understand all instructions during the intervention period. - exclusion criteria: suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, crohn's disease). suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia). have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder. take medication for depression or low mood. suffering from internal organ failure (such as heart, liver or kidney failure, etc.). have received radiotherapy or chemotherapy in the past. have received general anesthesia surgery/procedures within the past three years, or plan to receive general anesthesia procedures/surgeries within the next three months during this trial. have suffered from hepatitis (hepatitis b, hepatitis c), hiv or syphilis in the past. -
participatory action research to evaluate the delivery of the mission abc service model and assess health service and clinical outcomes

Conditions: COPD; Asthma; Breathlessness

Summary: innovations aimed at improving new patient identification, diagnosis, nonpharmacological treatment, supported self-management, and remote monitoring, together with new methods of clinical support could improve outcomes in patients with respiratory disease. the investigators have developed a model of care incorporating key innovations for patients with asthma, copd and undifferentiated breathlessness. this service is being implemented within wessex ccgs. the investigators will assess whether the implementation of the service is effective, and how it can be adjusted, in addition to introducing innovations to assess whether the expected benefits for patients are realised.

a combination of study designs are required to evaluate all aspects of the service: * participatory action research approach, involving real-time evaluation at each clinic to inform subsequent clinics * before-and-after study for patient outcomes pre-clinic attendance and post-clinic attendance. * qualitative methods (interviews, focus groups) evaluation of the clinic cycles will include consideration of qualitative data from patients, carers and healthcare professionals, in addition to quantitative outcomes for service implementation and patient factors (i.e. uptake of the service and benefits realised in-session), including those in the following areas: * clinic process * education and supported self-management * added value of diagnostic tools (new diagnoses) * applicability and use of treatment tools and treatment tailoring * self-monitoring appropriateness and uptake * balance measures (e.g. increased secondary care traffic) the longer-term impact of the service will be evaluated using clinical and health service outcomes such as: * hospitalisations for airways disease * perceived disease control (symptom scores etc) * exacerbation frequency * health-related quality of life * patient activation measures (pam) * treatments used * healthcare resource use (primary and secondary care)

Eligibility criteria:
inclusion criteria: * attendance at a mission abc clinic or training session as a patient, carer or healthcare professional exclusion criteria: * unable to give informed consent * level of literacy precludes inclusion in questionnaire-based study
diagnostic accuracy of optical coherence tomography in upper urinary tract urothelial carcinoma

Conditions: Transitional Cell Carcinoma of Urinary Tract

Summary: the purpose of this study is to establish in vivo sensitivity and specificity of oct in the diagnosis of upper urinary tract urothelial carcinoma.

minimal invasive endoscopic treatment for upper urinary tract urothelial carcinoma (uut-uc) has been accepted as a treatment option instead of radical nephroureterectomy for patients with low grade, low stage disease. for this reason, information on tumour stage and grade is important for a clinical decision. until now,diagnostic ureterorenoscopy combined with histology/cytology is the gold standard. unfortunately, histology/cytology is often inconclusive. optical coherence tomography is a new high resolution imaging technique that has potential to provide the urologist real time per-operative information of grade and stage of the disease. in this study the investigators aim to establish in vivo sensitivity and specificity of oct in the diagnosis of upper urinary tract urothelial carcinoma. secondary objectives are inter-observer variability of 1300 nm oct in the diagnosis of uut-uc and optical properties of cancerous and healthy ureter and collecting system tissue in vivo in humans.

Eligibility criteria:
inclusion criteria: * candidate for diagnostic or therapeutic ureterorenoscopy * signed informed consent exclusion criteria: * no signed informed consent

Keywords: upper urinary tract optical coherence tomography transitional cell carcinoma urothelial cell carcinoma diagnostic accuracy
vaccination course in primed children and age-matched unprimed children with pneumococcal vaccine gsk1024850a

Conditions: Infections, Streptococcal

Summary: the purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine gsk1024850a in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine gsk1024850a in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine gsk1024850a in age-matched unprimed children. the study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine gsk1024850a in the first year of life. the study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine gsk1024850a in the fourth year of life. this protocol posting deals with objectives \& outcome measures of the booster phase. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct number = 00307034)


Eligibility criteria:
inclusion criteria: * male or female between, and including, +- 36-46 months of age at the time of vaccination. * for primed subjects: having completed the full vaccination course with gsk1024850a in the primary study (nct00307034). * subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s)/guardian(s) of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination. * for primed subjects: administration of any pneumococcal vaccine since the end of the primary study (nct00307034). * for unprimed subjects: previous vaccination with any pneumococcal vaccine. * administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * history of reactions or allergic disease likely to be exacerbated by any component of the study vaccine. * acute disease at the time of enrolment.

Keywords: pneumococcal vaccine pneumococcal disease safety immunogenicity
assessment of volume status by bedside ultrasound in children with acute gastroenteritis

Conditions: Dehydration; Acute Gastroenteritis

Summary: the purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis

the research will be conducted of emergency medicine department in the derince training and research hospital. patients referred to acute gastroenteritis will be included to the study. after initial evaluation, the clinician will inform the principal investigator about the patient. the principal investigator will record the patient's demographic data, contact information, vital signs, history, physical examination findings, and weight. than expirium and inspirium diameters of vena cava inferior will be measured with the bedside ultrasound and caval index will be calculated. an investigator who have had an ultrasound certification by emergency medicine association of turkey for six years will make the measurements. after 1 week the patient will called up for re-evaluation. applicants' weights will be measured again with the same weighing machine. the differences between initial and after one week weight measurement will be accepted as the gold standard method for volume loss. the weight loss of the patient, the dehydration findings detected on physical examination and the caval index will be compared. data will be collected on predesigned data sheets, by an investigator and subsequently will be entered into a spreadsheet (excel 2007; microsoft, redmond, wa). all recorded data will be checked by an another investigator to identify possible errors. results will be submitted at least every two months. linear regression will be performed with dehydration as the dependent variable and the caval index as the independent variable.

Eligibility criteria:
inclusion criteria: * patients between 6 months and 18 years of age who presented to the emergency department with gastroenteritis exclusion criteria: * congenital heart disease * chronic liver disease * chronic renal disease * patients or parents who doesn't want to enroll the study

Keywords: ultrasound pediatrics gastroenteritis
assessment of the 90-day mortality risk score after vats lobectomy

Conditions: Lung Cancer; Surgery--Complications; Morality

Summary: a five classes (a-e) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity \ 150 minutes (1 point), has been recently published. this study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.

from the italian vats group database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. we calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. the correlation between risk classes and mortality rates was tested by spearman's rho-test. model calibration was evaluated by hosmer-lemeshow goodness-of-fit test.

Eligibility criteria:
inclusion criteria: - patients undergoing vats lobectomy for non-small cell lung cancer exclusion criteria: * incomplete data for risk score calculation * tumor size \>5 cm * follow-up \<3 months * patients undergoing neoadjuvant treatment * patients undergoing extended resection

Keywords: non-small cell lung cancer vats lobectomy 90-day postoperative mortality risk score validation
paraclinoid aneurysm prospectively driven observational analysis (pandora) study

Conditions: Unruptured Aneurysm of Carotid Artery

Summary: the optimal consensus concerning treatment of incidental small paraclinoid unruptured intracranial aneurysms (uias) remains controversial. the aim of this prospective study is to reveal the natural history of small paraclinoid uias with the goal of informing the treatment plan.

a prospective observational study will be conducted in 13 korean centers enrolling a consecutive series of 645 patients with small paraclinoid unruptured intracranial aneurysms (uias) from 2015 to 2017. the investigators defined the cohort population as adults(20 years old or more) with small (less than 5mm) unruptured paraclinoid aneurysm. to determine the growth rate and risk factors, the angiographic features based on mra or cta(ex) size, arterial relationship, multiplicity)and the clinical characteristics (ex) age, hypertension (htn), diabetes mellitus(dm), hyperlipidemia, smoking) are recorded at initial visit, 1 year, 2years, 3years, and 5years. the cumulative risk and the risk factors of aneurysmal rupture and growth will be analysed.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed small unruptured paraclinoid aneurysms who agreed to participate. * 20years old or more * less than 5mm in maximum diameter * neurological status of patients should be satisfied with less than modified rankin score 2 or more than 70 in karnofsky performance score exclusion criteria: * patients had previous subarachnoid hemorrhage that could be related to the rupture of paraclinoid aneurysm. * traumatic, infectious or dissecting aneurysms * fusiform aneurysms * aneurysms that related to other vascular disease or brain tumor * aneurysm that associated with the atherosclerotic change of a parent artery

Keywords: small paraclinoid